It’s an exciting time to join us!

 

The Andelyn Biosciences’ Quality Assurance group is seeking a motivated individual to join our growing team as a GMP Senior Specialist - Validation.

 

The Quality Assurance GMP Senior Specialist – Validation is responsible for managing validations related to manufacturing product, process, equipment, and facility, contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance. In this critical QA role, you will lead as a Subject Matter Expert in a newly formed CDMO quality assurance team that thrives on exciting science and collaboration with internal and external partners. This newly created position has the opportunity to engage in a variety of projects at various stages of development but primarily focuses on Phase 3 and commercial Quality Assurance through the direct project management of varying complexities of equipment, test method and process validations initiated for the GMP operations of a newly constructed manufacturing facility. In addition, this specialist will support site validation activities as a QA SME in the review and approval of quality documentation for these activities. 

 

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Quality Assurance Manager, essential functions of the Quality Assurance GMP Senior Specialist - Validation include at a minimum:

·       Review/Manage equipment, process, and test method validations, and Quality review and approval associated activities for a newly constructed cell and gene therapy CDMO facility.

·       Support Regulatory Agency submissions and audits by being a Subject Matter Expert in the assigned area.

·       Review and audit complex documents: batch records, GMP protocols, process and method validations in compliance with QMS, policies, and procedures.

·       Observe manufacturing activities to support the implementation of best practices and improvements; including transfer of site knowledge to new facility start-up activities.

·       Support technology transfer initiatives, as assigned.

·       Manage QMS; author, review, and approve SOPs and Policies for the new facility.

·       Prepare routine updates and project status reports of Quality Assurance activities.

·       Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.

·       Ensure that documentation is maintained in accordance with internal procedures and regulatory requirements.

·       Support, prepare and provide Quality training with cross-functional teams as assigned.

·       Mentor and provide guidance to less experienced Specialists within the QA Validation team.

·       Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.

 

Knowledge, Skills, and Abilities required:

·       Minimum of 5 years’ experience GMP/Biopharmaceutical/Biotech Industry, cell and gene therapy experience preferred; change control experience a must

·       Bachelor’s Degree in a technical or scientific discipline or equivalent

·       Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211

·       Experience in commercial and clinical GMP production and ability to provide QA support for both

·       Knowledge of FDA regulations, European Directives, ICH guidelines, and cGMP regulations, regulatory inspection experience preferred

·       Demonstrated Project Management abilities to lead and manage several projects, meet deadlines, and use critical thinking skills to problem-solve effectively.

·       Excellent verbal and written communication skills to all levels of the organization. Technical writing required.

·       Strong experience as an individual contributor working in cross-functional teams. Ability to influence, negotiate, manage conflict and collaborate.

·       Must demonstrate a “can-do” attitude. 

·       Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.

 

 

Minimum Physical Requirements

·       There are very minimal physical requirements. 

·       One needs to be able to lift 20-30 pounds occasionally, bend, reach or balance (0-33% of the time).

·       Requires ability to aseptically gown or wear other PPE required as needed.

·       Must be able to stand/sit for extended periods.

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this position. It is not to be construed as an exhaustive list of duties performed by the individual notified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

 

EOE M/F/Disability/Vet

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to the first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.